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Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke (SERICT-AIS)

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ClinicalTrials.gov Identifier: NCT04027621
Recruitment Status : Completed
First Posted : July 22, 2019
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Yi Yang, The First Hospital of Jilin University

Brief Summary:
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Device: remote ischemic conditioning Device: sham remote ischemic conditioning Not Applicable

Detailed Description:
In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times within 6 hours to 24 hours from thrombolysis. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times within 6 hours to 24 hours from thrombolysis . Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning combined with intravenous thrombolysis in treating acute ischemic stroke.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of Remote Ischemic Conditioning Combined With Intravenous Thrombolysis in Treating Acute Ischemic Stroke
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 20, 2020

Arm Intervention/treatment
Active Comparator: RIC group
RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.
Device: remote ischemic conditioning
Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.

Placebo Comparator: control group
Sham RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice twice within 6 to 24 hours from thrombolysis. Additionally,the patients will be treated with standard medical treatment according to Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014
Device: sham remote ischemic conditioning
Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.




Primary Outcome Measures :
  1. Frequency of adverse events during hospitalization [ Time Frame: 7 days ]
    All adverse events until day-7 or discharge (whichever is earlier)

  2. Frequency of adverse events during follow-up [ Time Frame: 3 months ]
    Severe adverse events through day-90 after the onset of acute ischemic stroke.


Secondary Outcome Measures :
  1. National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge [ Time Frame: 7 days ]
    National Institute of Health stroke scale (NIHSS) at 7 days from onset or discharge. Ranged from 0 to 42, a low value represents a better outcome.

  2. Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 [ Time Frame: 3 months ]
    Proportion of patients with Modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.


Other Outcome Measures:
  1. Changes of hematological indicators [ Time Frame: 24 hours ]
    Hematological samples are collected at right before thrombolysis and 24 hours after thrombolysis, and changes of hematological indicators related to hemorrhagic transformation (such as Axl, ANGPTL4) are compared between the two groups.

  2. Changes of the function of dynamic cerebral autoregulation [ Time Frame: 10 days ]
    The function of patients' dynamic cerebral autoregulation are tested 3 times within 10 days from onset and compared between the two groups.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) Age≥18 years, < 80 years, regardless of sex;
  • 2) Patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis;
  • 3) Baseline NIHSS >= 5, and <= 25;
  • 4) Baseline GCS ≥8;
  • 5) Signed and dated informed consent is obtained

Exclusion Criteria:

  • 1) Patients who undergo endovascular treatment;
  • 2) mRS ≥ 2 before the onset of the disease;
  • 3) Double upper limbs or lower limbs paralysis was found in this case;
  • 4) Active bleeding of organs within 6 months of admission or current, including cerebral hemorrhage, subarachnoid hemorrhage, gastrointestinal hemorrhage, fundus hemorrhage and so on;
  • 5) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumor and other diseases involving the brain;
  • 6) Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban;
  • 7) Severe organ dysfunction or failure;
  • 8) Patients suffering from severe hematological diseases or severe coagulation disorder dysfunction
  • 9) Those who have a history of severe trauma or had major surgery within 6 months prior to admission;
  • 10) Those who have a history of atrial fibrillation;
  • 11) The patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb#Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
  • 12) Pregnant or lactating women;
  • 13) Previous remote ischemic conditioning therapy or similar treatment;
  • 14) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons;
  • 15) Severe hepatic and renal dysfunction;
  • 16) Unwilling to be followed up or treated for poor compliance;
  • 17) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission;
  • 18) Other conditions that the researchers think are not suitable for the group.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027621


Locations
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China, Jilin
The First Hospital of Jilin University
Chang chun, Jilin, China, 130000
Sponsors and Collaborators
Yi Yang
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Responsible Party: Yi Yang, Associated Dean of First Hospital of Jilin University, The First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT04027621    
Other Study ID Numbers: SERICT-AIS
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis